PIL in Supreme Court by Sama and others

Sama along with other petitioners filed a PIL in the Supreme Court that raises the issue of unethical conduct of HPV clinical trials conducted in Andhra Pradesh and Gujarat between 2009‐2010 by PATH in collaboration with ICMR. The PIL highlights the serious failures to comply with legal and ethical requirements vis-a-vis informed consent, adverse events and ensure medical management of short and long term injuries of participants. The failure of the Ethics Committees in protecting the rights of trial participants by allowing the trial to be conducted in young girls from socio‐economically backward families and where medical facilities were poor or non‐ existent, are also raised by the PIL.

It also challenges the recommendations of the Dr. S. S. Aggarwal Committee Report dated 15 February 2011, for failing to carry out an independent and unbiased investigation into the conduct of the trials. The overall thrust of the petition is that the current ethical and legal framework to protect subjects of clinical trials is grossly inadequate and needs to be re‐examined. On 11 November 2013, the Hon’ble Chief Justice P. Sathasivam and Justice Ranjan Gogoi of the Supreme Court issued notice to all the respondents, which includes, PATH, ICMR, the Union Ministry of Health, State governments of AP and Gujarat and the Ethics Committee Members (HPV trials).

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